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Renatron® II Service Maintenance Seminar. Class Schedule. DAY ONE 8:30 AM- Seminar start: Introduction 10:00 AM- Break 12:00 PM- Lunch 2:30 PM - Break 5:00 PM- End of first day. Class Schedule. DAY TWO 8:30 AM- Seminar start 10:00 AM- Break 12:00 PM- Lunch 2:30 PM - Break
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Class Schedule DAY ONE 8:30 AM- Seminar start: Introduction 10:00 AM- Break 12:00 PM- Lunch 2:30 PM - Break 5:00 PM- End of first day
Class Schedule DAY TWO 8:30 AM- Seminar start 10:00 AM- Break 12:00 PM- Lunch 2:30 PM - Break 3:30 PM- End of Seminar
Cautions The Renatron® 100 is intended only for use with Renalin® 100 Cold Sterilant Used only for Hemodialyzers that have been labeled multiple use. Never run the machine without the uptake tube assembly All hoses and lines for the Renatron® are cut to length and should not be altered.
Indications The Renatron® Dialyzer Reprocessing System is intended for in vitro, rinsing, cleaning testing, and delivery of proportioned Renalin® solution to hollow fiber dialyzers that have been validated to be reprocessed with the Renatron® II System and Renalin® sterilant. It is also indicated for record keeping of these functions.
Electrical Leakage Current 100 micro amps Selectable voltage 100, 120, 230, 240 VAC The supply line voltage must not fluctuate more than 10% of the nominal voltage. Fuses 100-120vac, one 4A Fuses 220-240vac, two T2A
Environmental Limits Operation Ambient Temperature Range 41-104° F (5-40° C)
Water Requirements Water must be filtered to particle size no larger than 1 micron. Inlet Water Must Meet or Exceed AAMI Guidelines
Water Temperature Must be 59 -75°F (15-24° C) A maximum temperature of 86° F is allowable if the dialyzer is stored immediately after reprocessing in an area where the temperature is between 59-75° F. (Must have letter)
Feed Line Flow 1.725 liters (.46 gallons) per minute average Maximum water pressure is 55 PSI static Minimum water pressure is 20 PSI dynamic read in step 4. Optimum pressure of 30-35 PSI in Step 4.
Peak Flow Rate 6 liters (1.6 gallons) per minute 15-35 seconds in duration Occurs at approximately 3 minute intervals 3 times per cycle
Drain Requirements Must be able to accept 6 liters (1.6 Gallons) per minute per Renatron®.
Materials of Construction The drain should be constructed of PVC/CPVC or other Non-corrosiveMaterial
Renatron® II Station Components Renatron® II Dialyzer Reprocessing Station Has a hydraulic side and electronic side. 1 - 6 ft water supply hose with back flow preventor. 1 - 6 ft drain hose. 1 - 6 ft Renalin® hose. 1 - 6 ft RS-232 communication cable
Renatron® II Station Components • Pressure gauge block/regulator • 70 cc cal cell • Drip tray-single or dual • Renalin®100 Uptake tube assembly
Renatron® II Station Components • Computer • Top of the line computer system • Windows XP Monitor • VGA Monitor- CRT or Flat Screen
Renatron® II Station Components • Renalog RM Data Management System • Dedicated label printer • Dedicated Report Printer • Interface Module • Multiplexing module that can connect up to 6 Renatrons®. • Renalog RM – 12 Renatrons per computer
End of Treatment After treatment is completed, the dialyzer is brought to the reuse room. The time interval between the end of the treatment and reprocessing the dialyzer should be kept within the time limits prescribed by the physician The suggested maximum time interval is two hours
Dialyser Cleaning Many clinics will clean or rinse a dialyzer before reprocessing. Blood side flush RUF Renaclear®
Reprocessing • Attaching a dialyzer Connect: • Venous blood side • Venous dialysate side • Arterial dialysate side • Arterial blood side
End of Reprocessing Cycle Make sure reset is pressed before the dialyzer is disconnected. Disconnect the dialyzer in the reverse order that it was connected. Cap each port as soon as it is disconnected from the Renatron®. Aseptic technique must be followed while removing the reprocessed dialyzer from the Renatron® station to prevent contamination of the dialyzer blood pathway
Dialyzer Storage Storage Area Well ventilated Temp. range 59-75°F Out of direct Sun light Dialyzer Storage Minimum storage time is 11 hours Maximum storage time ? Temperature differences may cause pressure buildup in dialyzer
Dialyzer Testing before Treatment The dialyzer must be tested for Renalin® 100 content after proper storage time- Perrassay Test Strip The dialyzer is rinsed on the dialysis machine and a Residual Test Strip is used to verify that the Renalin® 100 content has been rinsed to acceptable levels Recirculate until treatment is started to prevent rebound
Power Up Sequence Power on sequence Printers Monitor Computer Interface module Renatron® II All at once if using the power strip
Renalog® RM Start Up • Log in • User ID • Password • Mode • Change Time- Activation key needed • Start Up Screens • Renalin Verifications • Service Rinse • Sanitize Renatrons • Calibration • Water Verifications- 20 psi to 55 psi • Water Cultures • Dialyzer Verifications- Precleaned, Expired, and not Processed
Renatron® II 100 Startup Renalog® RM Startup Renalin® 100 is connected The Renatron® II 100 is sanitized The Renatron® II 100 is calibrated Static and dynamic water pressure readings
Renatron® II 100 Startup Calibration verification Scan barcodes- Authentication label, Renatron, and Dialyzer The Renatron® II 100 runs to step 57 Calibration information is stored in the computer and a calibration report can be generated.
Program Mode Low flux dialyzers (00) kuf <8. Program time = 8 minutes. High efficiency dialyzers (CH) kuf 8-15. Program time= 10 minutes. High flux dialyzers (HF) kuf 15+. Program time = 10 minutes.
Automatic Reprocessing Scan Authentication label, dialyzer barcode label, and Renatron® barcode. Minimum Volume Program Mode When reset is pressed in step 57, labels are printed and the database is updated.
Semi-Automatic Click on F6 to display Patient list Select patient’s dialyzer Select type of reprocessing Preclean Reprocess without a use Reprocess after use Sets the Renatron® II 100 to the proper settings for that dialyzer
Manual ReprocessingWith Computer Process dialyzer on Renatron® II 100 Set Hold to Set volume to dialyzer minimum volume setting Press mute and reset button to select program setting At end of cycle, enter information into computer Preprocess Reprocess without use Reprocess after use Renatron number Container number Current Volume Did the dialyzer fail?
Manual Reprocessingwith Renatron® II 100 only Process dialyzer on Renatron® II 100 Set Hold to Set volume to dialyzer minimum volume Press mute and reset button to select program setting At end of cycle, hand write label
Pre-clean Mode • Pre-cleaning a dialyzer will help breakdown residual blood in the dialyzer. • Pre-clean program works for all types of dialyzers. Program time 4 minutes. • Recommended contact time for pre-cleaned dialyzers is 10 minutes to two hours.
Caution Pressure buildup may occur in dialyzers left on the Renatron® Take care when removing the dialyzer Pressure buildup may cause fluid to spray
User Authentication Label Information Label Barcode labels Dialyzer Barcode Label Pre-Cleaned Label Calibration Cell Label Failed Label
Daily Sanitize • The Renatron needs to be sanitized once a day. • The machine must be connected in sanitize configuration. “SEL” must be in the top display and any of the programs “00”, “CH” or “HF” in the bottom display before “Start Sanitize” is pressed • The machine will display “sanitize complete” and a 3 second tone will sound at the end of step 83. • Turn off the Renatron and the water supply to the Renatron.
Minimum Sanitize Time • The Renatron must sit for a minimum of 6 hours before it can be used.
Maximum Sanitize Time The Renatron® can sit for a maximum of seven days before it needs to be resanitized.
10 Minute Sanitize Cycle • Press start process at the end of step 83, after a 10 minute hold in step 84, the machine will run to step 97, and signal sanitize complete. All fluid will be removed from the machine. • This cycle is to be used after a 409® procedure, when maintenance is performed on the machine, or when the machine is being returned for maintenance.
External Disinfection(Daily) 1 % Renalin® solution is used to wipe down external surfaces of the Renatron® station Actril® undiluted is also acceptable
409® Cleaning Institutional Formula 409® Institutional Formula 409® Cleaner Degreaser only Must say NQF Do not use any other solutions Internal fluid pathways must be cleaned periodically ( typically once every two weeks ) This should be performed on Saturday a long dwell time is preferred
409® Cleaning Institutional Formula 409® is free when Renalin® 100 is ordered in proper quantities